To explore the responses, in terms of self-image and psychiatric symptoms, of women with breast cancer to an art therapy intervention

The art therapy intervention consisted of five sessions in which participants were encouraged to express feelings and thoughts. Participants’ pictures were used as a mode of expression, followed by reflective dialog. Two experienced art therapists conducted interventions and patient interviews, so that the therapist did not function as both interviewer and therapist for the same patient. Art therapy sessions were provided during adjuvant radiation therapy. Study data were collected at baseline, after two months, and after four months.

• The study reported on a sample of 41 patients.
• Median patient age was 59 years, with a range of 37–69 years.
• All the patients had breast cancer (100% female sample) and had received adjuvant radiation therapy. No other specific diagnostic information was provided.
• No demographic data were reported (other than age). A few patients in both groups were receiving antidepressants. About 50% of patients had received chemotherapy prior to radiation therapy, and 41% had received hormone therapy.

• Single site
• Outpatient setting
• Sweden

• Phase of care: active treatment
• Clinical applications: late effects and survivorship

Randomized controlled trial with longitudinal analysis

• Structural analysis of social behavior
• Symptom Checklist-90 (provides symptom-subscale scores and measures of general severity)
• Interview

At baseline, all participants had similar self-image scores and scores for depression, anxiety, and general symptom severity as a group of females undergoing radiation therapy for breast cancer who are otherwise healthy. Those who received art therapy showed a decrease in symptoms of anxiety and depression (p < 0.01). Control patients’ symptom levels remained essentially stable. Regression analysis showed that surgery, chemotherapy, parenthood, and study group were significant predictors of depression and anxiety as measured at the end of the study (p < 0.05). Axillary surgery and hormonal treatment predicted higher ratings of anxiety. Subjects’ positive and negative self-image scores were not different between study groups and did not differ significantly from healthy controls.

Participation in art therapy was related to lower patient ratings of depression, anxiety, and somatic symptoms. Axillary surgery and hormonal treatment were predictive of higher levels of anxiety and depression.

• The study had a small sample, with fewer than 100 participants.
• No attentional control was provided.
• It is unclear whether art therapy sessions were provided individually or in groups, a factor that could have affected results.
• There was an overall drop-out rate of 24% from the initial randomized sample.
• Baseline scores relating to depression and anxiety were actually lower in study patients than those of a healthy comparison group, leading one to question the clinical relevance of study findings overall.
• Measurement methods used in the study did not include those commonly used in other research.
• Authors reported minimal demographic informatio, a factor that may limit generalizability.

Findings suggest that art therapy might be helpful in management of symptoms of depression and anxiety in women with breast cancer; however, the clinical relevance of findings is unclear. Further well-designed research is needed to confirm these preliminary findings.

To assess the efficacy and 12-week tolerability of intranasal fentanyl spray (INFS) in patients with cancer-related breakthrough pain

Doses were titrated to achieve efficacy. Patients with doses titrated to 200–400 mcg were entered into an efficacy phase in which eight episodes of breakthrough pain were treated. Episodes were randomly treated with INFS or a placebo. Patients with doses titrated to 50 or 100 mcg were directly entered into a tolerability phase. Patients with titrated doses of 200 or 400 mcg entered a tolerability phase after the treatment of eight breakthrough episodes. Patients recorded pain, adverse effects, and impressions of efficacy daily in a diary. Pain was recorded at baseline and at two, 10, 30, and 60 minutes after taking INFS. Local nasal tolerability was assessed by an otorhinolaryngologist at baseline and at the end of the study.

• N = 46
• MEDIAN AGE = 61 years (range = 38–79 years)
• MALES: 32.6%, FEMALES: 67.4%
• KEY DISEASE CHARACTERISTICS: Most frequent tumor types were breast, urothelial, and gastrointestinal; 54% had bone metastases

• SITE: Multi-site  
• SETTING TYPE: Not specified  
• LOCATION: Several European countries

Double-blinded, placebo-controlled, crossover trial

• 11-point Numeric Rating Scale (NRS)  
• The difference between pain ratings at baseline and each time point for breakthrough episodes was calculated.
• Clinical nasal examination

Mean differences in pain were greater for INFS compared to a placebo at 10, 30, and 60 minutes (p < 0.02). In total, 61% of patients receiving 400 mcg responded at five minutes. The most common adverse nasal events were change in mucosa color, runny nose, inflammation, stuffed nose, and edema, which occurred in four to five cases. None were considered serious. Other events reported were dizziness, nausea, fatigue, and vomiting. Half of these were considered to be treatment-related. The adverse event profile was similar for all dose levels.

INFS was effective for the management of breakthrough pain compared to a placebo, and it was not associated with severe nasal side effects over a 12-week period. Other side effects seen were those typical of opioid treatment.

• Small sample (< 100)
• Measurement validity/reliability questionable
• Other limitations/explanation: Reliance on patient diaries for pain reporting at specific time points; adherence and missing data were not discussed

This study added to the body of evidence showing that INFS is effective in the management of breakthrough pain. The rapid, effective relief of breakthrough pain is an important goal for pain management. The examination of the nasal cavity in this study added to relevant information, showing its overall tolerability over a 12-week period. Ongoing research with longer periods of follow-up are needed.

STUDY PURPOSE: To summarize evidence and quantify the effects of reiki on pain and anxiety

• FINAL NUMBER STUDIES INCLUDED = 7
• TOTAL PATIENTS INCLUDED IN REVIEW = 328
• SAMPLE RANGE ACROSS STUDIES: 16–60 patients
• KEY SAMPLE CHARACTERISTICS: 48% women; mean age 63 years; three studies were in patients with cancer; two studies tested the intervention in a surgical setting; two studies used reiki in community-dwelling adults

The effects sized for within-group differences ranged from d = 0.24 for decreased anxiety in women undergoing breast biopsy to d = 2.08 for decreased pain in community-dwelling adults. For reiki versus a rest intervention in patients with cancer, the effect for a decrease in pain was d = 0.032, and the effect in community-dwelling adults was d = 0.45. A detailed discussion of individual studies showed some mixed findings, particularly for one study in which reiki was compared to both sham reiki and usual-care groups. The median number of study participants was 24. It was noted that it took more than a year to recruit a small number of subjects in some trials. The timing, number of sessions, and specific applications of reiki varied.

Data were insufficient to draw any generalizations regarding the effects of reiki on anxiety or pain. The magnitude of the effect sizes calculated suggests Reiki may be helpful, but more rigorous trials with larger samples are needed to fully evaluate its efficacy.

• Limited number of studies with only three in patients with cancer
• Sample sizes were small
• No quality evaluation of studies was include
• Timing and length of the intervention varied substantially, and most were for very short durations with few reiki sessions

This review did not demonstrate clear efficacy of reiki for pain or anxiety. However, the effect sizes shown here suggest that additional, wel- designed research is warranted. The authors made a note of the difficulty in recruiting patients to these trials and high attrition rates, particularly in the control groups. They suggested that the of a crossover design would be helpful to address these problems. The timing and length of treatment needs to be considered based on the desired effects and context of the patient situation. As much as possible, the standardization of the reiki intervention and the use of a sham control would be helpful to evaluate potential placebo effects.

• FINAL NUMBER STUDIES INCLUDED =  12
• TOTAL PATIENTS INCLUDED IN REVIEW = 358
• KEY SAMPLE CHARACTERISTICS:  Mean age of 8.4 years, age ranged from 1–19 years; 55% male participants; 120 participants from Greece; 62% Caucasian; majority had hematologic cancer; many studies were conducted during painful procedures such as lumbar puncture and venipuncture.

PHASE OF CARE: Multiple phases of care

APPLICATIONS: Pediatrics

Integrative interventions may be very effective for pain and anxiety in children undergoing cancer treatment. Integrative modalities, however, warrant further study with larger sample sizes to better determine their effectiveness in this population.

• No description existed of the time window during which data were extracted.
• Various interventions were combined and analyzed as a unit.
• Only included randomized controlled trials and thus reduced literature sample size
• The sample size for each intervention was small.
• The effect of each intervention is not clear.

This study provided some evidence that complementary modalities can help children undergoing cancer treatment or painful procedures. The usefulness of a particular method should be further examined.

The exercise intervention was a supervised, home-based, flexible training program in young and middle-aged patients with cancer shortly after curative chemotherapy. An exercise instructor designed the training program. The exercise period lasted approximately 14 weeks, with a minimum of two exercise sessions per week of at least 30 minutes. All types of activities were chosen, based on the patients’ wishes and opportunities. The intensity of the exercise was adjusted according to the patient’s subjective experience of tiredness. Data were collected at baseline and at three weeks (approximately 14 weeks).

The study reported on a sample of 111 patients (59 in the intervention group and 52 in the control group).

A randomized controlled trial design was used.

• Cardiorespiratory fitness (CRF)
• European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire
• Hospital Anxiety and Depression Scale (HADS)

CRF increased and fatigue scores decreased in the intervention group. There were no significant intergroup differences in mental distress or health-related quality of life. There were no statistically significant decreases in anxiety levels as measured by HADS.

The intervention required an exercise instructor.

Databases searched were MEDLINE, PubMed, EMBASE, Allied and Complementary Medicine (AMED), and PsycINFO. The dates encompassed by the search process were not specified by the authors.

Trials that provided data on the outcomes of physical activity in survivors of prostate cancer were identified. Studies that did not disentangle the effects of physical activity from a package of multiple interventions (e.g., physical activity combined with diet, counseling, etc.) were excluded. Studies that included survivors of prostate cancer among other cancer survivors without presenting separate results for survivors of prostate cancer were also excluded.

Six studies that examined the effects of physical activity in survivors of prostate cancer were identified. Of these studies, the physical activity interventions were performed during radiotherapy in one study and during androgen depletion therapy in five.  Four studies were randomized trials, whereas two were uncontrolled trials.

Outcomes were physical functioning, body composition, fatigue, and quality of life.

Four studies examined the effects of supervised exercise programs, whereas two investigated the effects of home-based exercise programs. Three studies tested a resistance exercise program; one tested a home-based walking program; one tested a group-based lifestyle program designed to increase physical activity; and one used a home-based intervention with walking, stretching, and resistance activities with biweekly supervised group-based booster sessions. The length of the exercise programs ranged from four weeks to six months, with a median of 12 weeks.

Sample sizes ranged from nine to 155 participants (median sample size = 48).

In four of the six studies in which fatigue was measured and reported, statistically significant improvements in fatigue were noted.  All studies demonstrated that physical activity was safe and feasible for survivors of prostate cancer receiving treatment.

The objective of the study was to review the effectiveness of the use of single tunneled, valved pleural catheters in the treatment of symptomatic recurrent malignant pleural effusion following failed chemical pleurodesis.

Two hundred seventy patients who underwent placement of a tunneled pleural catheter between January 2002 and December 2006 were identified after reviewing interventional radiology billing records. After subsequent review of inpatient and outpatient medical reports for each case, 63 were reportedly treated for dyspnea associated with recurrent malignant pleural effusion following failed pleurodesis. In the incidence of suboptimal drainage post-procedure, fibrinolytic therapy with tissue-type plasminogen activator (tPA) dissolved in saline was administered into the catheter to dwell for two hours in the pleural space prior to drainage and was repeated at one- or two-day intervals, if clinically required for optimal drainage and symptom relief. Catheters were drained every other day until the volume decreased to 50 mL, in which case it was drained every three days. Catheters were subsequently removed from patients who achieved durable symptom relief on three consecutive drainages during the three-day intervals with less than 50 mL of drainage and who had no radiographic evidence of re-accumulation. For those with larger drainage volumes, however, catheters were left in place for continued use.

• Sixty-three of the 270 identified patients underwent pleural catheter placement for treatment of dyspnea associated with recurrent malignant pleural effusion (68 were documented hemithoraces).
• The mean age was 61 years, with a range of 30-85 years.
• Of the sample, 30.2% were males, and 69.8% were females.
• Of the 63 patients identified, malignancy was as followed: breast (22), lung (14), ovarian (7), pancreatic (4), primary peritoneal (4), mesothelioma (2), esophagus (2), carcinoid (2), chronic lymphocytic leukemia (1), colorectal (1), melanoma (1), cervical (1), squamous cell (1), and adenocarcinoma of unknown primary (1).
• Nine patients had pre-existing pigtail drainage catheters prior to placement of the tunneled catheter.
   

This single-site study was conducted in both inpatient and outpatient settings in Interventional Radiology.

• Patients were undergoing long-term follow-up care.
• The study has clinical applicability for end-of-life and palliative care.
   

The study was a retrospective review.

Dyspnea was measured, but the scale or instrument used was not defined.

• Sixty of 63 patients experienced “immediate clinical improvement in dyspnea” following catheter placement. No clear symptomatic improvement was noted in the remaining three.
• Fifty-seven of 63 patients (90%) were discharged from the hospital with a tunneled pleural drain after a median of three days (range 0-29 days).
• Twenty-one of the 68 hemithoraces (31%) required subsequent fibrinolytic therapy to promote drainage of complex pleural effusions.
• One patient had the pleural catheter removed prior to discharge, while five patients died before discharge.
• Twenty-seven patients (43%) were discharged in two days or less.
• Those with longer hospital stays were due to treatment of other disease-related medical conditions.
• Symptomatic recurrence of pleural effusion occurred in one patient 19 days after tunneled pleural catheter removal requiring catheter drainage.
• Median survival following catheter placement was 64 days (range 34-164 days).
• Mean follow-up for survivors was 746 days.

The large majority of patients (95%) experienced prompt symptom relief and clinical improvement following tunneled pleural catheter insertion. Parynchymal lung disease or rapid progression of disease was reported among the patients who did not improve from catheter placement.

• The study had a small sample size of less than 100.
• Authors did not describe how dyspnea was measured and evaluated pre- and post-catheter placement, making it hard to quantify/gauge the extent to which patients experienced symptomatic relief of dyspnea.
• Authors were unable to analyze the durability of symptom relief due to lack of “uniformity” of clinical follow-up and documentation (i.e., regarding patients' drainage schedule, drainage volumes, symptoms, imaging).
   

Use of tunneled pleural catheters for the treatment of recurrent malignant pleural effusion appears to be an appropriate and beneficial intervention for patients suffering from dyspnea following failed pleurodesis. The majority experienced immediate symptomatic relief of their dyspnea following catheter placement, although one-third of cases may necessitate transcatheter fibrinolytic therapy for adequate drainage. As noted by the authors, it is less invasive and more cost-effective than more successful, though high-risk interventions such as decortication (which is 100% effective but associated with high morbidity and mortality and not recommended for this population), thoracentesis (which offers immediate symptomatic relief but is associated with 98%-100% recurrence within 30 days), or thoracoscopy with talc poudrage (which has a high success rate but is more invasive and requires general anesthesia). It is also worth noting the short hospitalization period reported for 43% of the patient population, who were discharged within two days of catheter placement and symptom relief. However, effectiveness for patients with progressive disease remains questionable.

The study explored a homeopathic approach to treatment of estrogen-withdrawal symptoms in women with breast cancer.

Active intervention was a homeopathic approach, which included a 60-minute consultation and the prescription of an individualized homeopathic remedy. A total of 25 remedies were used for the first prescription. Pulsatilla, Sepia, and sulfur were each used on more than three occasions for the first prescription.

The study enrolled: 45 participants who ranged in age from 34 to 71 years; just over half were aged 50–59 years.

• Inclusion criteria:
  • 45 consecutive patients seen at the outpatient clinic at Glasgow Homeopathic Hospital with breast cancer and estrogen withdrawal symptoms 
  • 32 participants were taking tamoxifen
  • 21 had undergone adjuvant chemotherapy
  • 20 were taking medications such as antidepressants and clonidine
  • 3 had metastatic disease at study entry 
• Exclusion criteria: None

This was a prospective observational study.

The study used a numerical self-rating scale, where 0 = no problem, and 10 = tremendous problem, to identify patient symptoms. Hot flashes were rated as the most common symptom (n = 38).

A data table showed significant improvement in hot flashes between baseline and last visit (p < 0.001).

The study used a small, convenience sample of consecutive patients, some of who were taking antidepressants (not specified) and clonidine, which may both be used to manage hot flashes. The length of study and schedule of follow up visits were not apparent. Assessment of hot flash frequency and severity was not the primary outcome measure of the study, only one of several symptoms assessed. Primary endpoint was the “effect on daily living” scores. Homeopathy regimens were not defined, which could pose a problem for study replication. Exact reduction in hot flashes was difficult to determine.

To examine the safety and efficacy of subcutaneous methylnaltrexone for treating opioid-induced constipation in patients with advanced illness.

Patients were randomly assigned to receive either methylnaltrexone 0.15 mg/kg or placebo subcutaneously every other day for two weeks. Patients were permitted to continue their baseline laxatives and could use rescue laxatives. By day 8, the study drug dose (methylnaltrexone or placebo) could be doubled if patients had fewer than three rescue-free bowel movements. Patients in both groups who completed the two-week study were eligible to enter an open-label extension phase. During the extension trial, methylnaltrexone 0.15 mg/kg was offered as needed every 24 hours for up to three months. Subsequent doses could be increased to 0.3 mg/kg if there was no defecation.

• The study reported on a sample of 134 patients aged 18 years or older.
• Median age was 72 years (range 34-93) in the methylnaltrexone group and 70 years (range 39-98) in the placebo group.
• The sample comprised 27 men (43%) and 36 women (57%) in the methylnaltrexone group, and 31 men (44%) and 40 women (56%) in the placebo group.
• Patients had advanced illness, such as terminal cancer or other end-stage diseases with a life expectancy of at least one month, as well as opioid-induced constipation. 
• Patients were receiving a median opioid dose of 100 mg of oral morphine equivalent. 
• More than 50% of study participants had a diagnosis of terminal cancer.

• Multi-site
• 27 U.S. and Canadian nursing homes, palliative care centers, and hospice centers

The study has clinical applicability for the end-of-life and palliative phases of care.

This was a two-week, double-blind, randomized, placebo-controlled phase III study with a subsequent three-month, open-label extension phase.

• Global Clinical Impression of Change (GCIC)
• National Cancer Institute common toxicity criteria (CTC), version 2.0
• Numeric pain rating scale (0 = no pain and 10 = worst pain possible)
• Modified Himmelsbach Withdrawal Scale

Efficacy Analysis: Double-Blind Phase

• Forty-eight percent of patients in the methylnaltrexone group, as compared with 15% of patients in the placebo group, had rescue-free laxation within four hours of receiving the first dose (p < 0.001 for all comparisons).
• Sixty-eight percent of patients in the methylnaltrexone group, as compared with 45% of patients in the placebo group, had three or more rescue-free laxations per week (p = 0.009).
• The median time to laxation after the first dose was 6.3 hours in the methylnaltrexone group and 48 hours in the placebo group (p < 0.001).

Pain Scores and Opioid Withdrawal

• Both groups had stable scores on the Modified Himmelsbach Withdrawal Scale and no change in pain scores. 

Adverse Events

• Similar percentages of patients in both groups had at least one adverse event (AE), of which abdominal pain and flatulence were the most common.
• Most AEs were rated by investigators as being mild or moderate. 

Open-Label Extension

• Eighty-nine patients entered the open-label extension phase.
• Response rates to methylnaltrexone were consistent during the extension.

Methylnaltrexone as administered in this study was effective in inducing laxation in patients with advanced illness and opioid-induced constipation, without compromising analgesia or triggering withdrawal symptoms.

Calculations showed that a total of 130 patients (65 in each group) would allow detection of a difference of 30% to 35% in the proportion of patients having a laxation response. However, only 106 patients (52 in the methylnaltrexone group and 54 in the placebo group) completed the study.

Subcutaneous methylnaltrexone seems effective in treating constipation in patients with advanced illness and opioid-induced constipation without compromising analgesia or causing withdrawal symptoms. In this study, more than 50% of patients had a diagnosis of cancer; therefore, conclusions can likely be extended to patients with cancer. In addition, patients in this study were receiving a median opioid dose of approximately 100 mg of oral morphine equivalent. Many patients with cancer receive a larger dose; therefore, further study with increased doses of morphine equivalent is warranted.

To test the effectiveness of two interventions, compared to usual care, in decreasing attitudinal barriers to cancer pain management, decreasing pain intensity, and improving functional status and quality of life (QoL)

Patients were randomly assigned to one of three groups: control, standardized education, or coaching. Patients in the education and coaching groups viewed a video and received a pamphlet about managing cancer pain. In addition, patients in the coaching group participated in four telephone sessions facilitated by an advanced practice nurse–interventionist who used motivational interviewing techniques to decrease attitudinal barriers to cancer pain management. Questionnaires were completed at baseline and at six weeks after the final telephone call. Authors used analysis of covariance to evaluate differences in study outcomes among the three groups.

• The sample was composed of 227 patients—that is, patients who completed the end-of-study evaluation.
• In the control group, average age was 58.7 years; in the education group, 62.5 years; in the coaching group, 61.8 years.
• Of all patients, 90.1% were male and 9.9% were female.
• In the sample the most common cancer types were lung, prostate, and head and neck cancers. Breast and colon cancers, myeloma, and mixed types made up the remainder of diagnoses.

• Multisite
• Six outpatient oncology clinics (four Veterans Affairs facilities, one county hospital, and one community-based practice)
   

• Phases of care: multiple phases of care
• Clnical applications: late effects and survivorship

Randomized clinical trial

• Attitudinal-barriers assessment: Authors chose the Barriers Questionnaire (BQ), a 27-item instrument, 0–5 scale, to measure barriers to cancer pain management. Barriers include concern about side effects, concern about tolerance, fear of addiction, fatalism, fear of disease progression, desire to be a good patient, fear of injections, and concern about distracting the physician from curing disease.
• Pain assessment: The study used the Brief Pain Inventory, a  0–10 scale self-report, to assess intensity and quality of pain, the extent to which pain relief was obtained, and the extent to which pain interferes with function.
• Functional status: The SF-36, a 0–100 scale, assessed eight health concepts (physical functioning, role limitations because of physical health problems, bodily pain, social functioning, role limitations because of emotional health problems, general mental health, vitality, and perception of general health). Higher scores reflect higher functioning.  
• QoL: The study measured four QoL domains (physical, social, emotional, and functional well-being) by means of the FACT-G, a five-point Likert-type scale, with each subscale summed to obtain a subscale score and all individual items summed to obtain a total score. Total score can range 0–112.
   

• Authors found no differences among the three groups in any of the subscale or total BQ scores.
• Assessment of measures at the second time point found no differences among the three groups in regard to pain intensity or pain relief. However, at the end of the study, authors noted significant differences in mean pain interference scores (p < 0.01).
• The SF-36 showed significant differences among the groups in general health, vitality, mental health, and the mental component (as measured by summary score). The coaching group had higher mental health component scores than did the control group.
• Authors noted no significant differences among groups in regard to any of the FACT-G subscales or total scores.
• Patients in the coaching group reported a statistically significant decrease in pain-related interference with function and improved ratings of vitality, mental health, and general health. Compared to standardized education, coaching was associated with clinical improvements in cancer pain management (decreased cancer pain intensity and improvement or stability in functional status and QoL).

Findings suggest that coaching may be beneficial to cancer pain management, especially as management relates to collaborative development of individualized care plans that decrease symptoms.

• The fact that more than 90% of the sample was male may be a limitation. 
• The study employed a convenience sample, a fact that may limit applicability to other oncology populations. 
• The study did not alter the amounts or types of analgesics prescribed. This fact may limit results.   
   

Focused sessions consisting of 30 minutes of motivational-interviewing coaching by an advanced practice nurse may improve the management of cancer pain and overall health outcomes.